Companies that treat alcohol abuse or alcoholism with psychedelic drugs are rushing to develop a treatment. Awakn Life Sciences and atai Life Sciences both updated investors this week on the DMT drug they are developing for alcohol use disorder.
World Health Organization (WHO) estimates around 400 millions people worldwide suffer from alcoholism, and around 3,000,000 deaths are attributed each year to this condition. With such a large patient population, a solution would be a financial home run for these companies – not to mention the benefits to the patients.
Atai’s latest update
Atai Life Sciences announced topline positive results of Beckley Psytech’s open-label Phase 2a study on BPL-003 among 12 patients who had moderate to severe AUD. According to the company, a single BPL-003 dose combined with relapse treatment produced significant and sustainable reductions in alcohol usage, with 50 percent of patients remaining abstinent for at least three months. Atai expects the Phase 2b results of BPL 003 to be available mid-year.
We are encouraged by the exploratory results of Beckley Psytech. This strategic investment shows the potential for short-term in-clinic psychoedelic treatments to transform treatment of substance abuse disorders, said Dr. Srinivas RAO, CEO and founder of atai. This study’s high abstinence rates are especially promising, as patients with alcohol use disorders face significant difficulties in abstinence. The findings of this study add to a growing body of research that supports the effectiveness of BPL003 for treating mental disorders.
Atai BPL003 is an intranasal synthetic formulation protected under patent of 5-MeO DMT benzoate. This is designed to produce rapid and long-lasting treatment effects with just one single dose.
Awakn’s Update
Awakn Life Sciences Corp. has developed two drugs for treating AUD. They are AWKN-010 and AWKN 002 and they both have a ketamine basis. AWKN 001 is currently in phase 3 testing in the U.K. The company informed investors that it plans to submit a Regulations 52b hybrid application (UK) for AWKN-011.
The company stated that if the application is successful, it could grant 8 years’ exclusivity on the market, plus an extra 2 years for supplementary protection. This would prevent competitors from marketing similar products with the same indication.
Regarding AWKN002, the company stated that it had completed a PreInvestigational New Drug (PreIND) meeting, where the U.S. Food and Drug Administration confirmed AWKN002 could be reviewed using the 505(b2) NDA pathway. FDA has also confirmed that additional clinical data is not required to move forward with a phase 2b study in patients suffering from moderate-to-severe AUD.
Awakn announced in a release that the company plans to file an IND for AWKN-012 in 2025’s second half, and then a Clinical Test Application (CTA) for a Phase-2b trial in 2026’s first half. The company would have five-year exclusivity if all went well.
“We are excited about the progress across our key R&D programs, particularly in the areas of Alcohol Use Disorder and PTSD. Anthony Tennyson CEO of Awakn stated that with the advances we have made in AWKN-010 and AWKN-012, we are on track to provide transformative treatments for patients who need more effective solutions.
Green Market Report Graft Polymer PLC acquired all shares of Awakn for C$8.8 Million in December. The deal will close during the summer of 2020.